Supplementary protection certificates (SPCs) are not available for formulations of medicines that contain substances previously authorised for use in the EU, the EU's highest court has ruled.
The Court of Justice of the EU (CJEU) clarified that the EU's SPC Regulation precludes owners of pharmaceutical patents from obtaining SPCs to extend their rights in those products if they concern new formulations of old active ingredients.
SPCs serve to extend the life of a patent by up to a maximum of five years with respect to products which are authorised under the relevant regulatory framework in the field of medicinal and plant products. SPCs are provided for under EU regulations which are directly applicable across the whole of the EU, although they have to be applied for separately in each EU country.
The rationale for SPCs is to compensate patent holders for the period of patent protection during which they are prevented from commercialising their products owing to the lengthy approval process. Patent protection lasts 20 years but it often takes drugs companies around a decade to develop new medicines and gain marketing authorisation.
Under the SPC Regulation, SPCs can only be granted if, in the EU country in which the application is submitted, the product is protected by a basic patent in force and a valid authorisation to place the product on the market as a medicinal product has been granted. The product must not already have been the subject of an SPC and the authorisation must be the first to place the product on the market. It is this latter requirement which the CJEU considered in its ruling.
The CJEU held that the law makers intended the SPC Regulation to "protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product". Their purpose was not to protect "all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product", it said.
"Such an objective would be jeopardised if … it were possible to take into account, in respect of a new formulation of an old active ingredient, solely the first MA (marketing authorisation) to be covered by the scope of the basic patent protecting that new formulation and to disregard an MA which had been granted previously in respect of the same active ingredient in another formulation," the CJEU said in its ruling.
"Furthermore, such an interpretation … would risk leading to legal uncertainty and inconsistencies as to the circumstances in which an SPC may be obtained, as it would be difficult to determine in which specific circumstances an MA granted in respect of a new formulation of an old active ingredient may be covered by that provision," it said.
"Consequently, an MA granted for a new formulation of an old active ingredient … cannot be regarded as being the first MA granted for that product as a medicinal product … when that active ingredient has already been the subject of an MA," it said.
The CJEU's interpretation of the SPC Regulation had been requested by the High Court in London.
The High Court is considering an appeal by Abraxis Bioscience against a decision taken by the UK's comptroller general of patents. The comptroller refused Abraxis' application for a SPC for cancer drug branded ‘Abraxane’ on the basis that the pharmaceutical substance contained in the drug had already been marketed by other companies. The High Court asked the CJEU to help it interpret EU law before it makes a decision on the case.
The High Court will now have to apply the CJEU's ruling to Abraxis' case when it comes to issue its judgment on the case.
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